MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM 5PK; ARTHROSCOPE

Model Number	283422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by a field service engineer in australia that during a knee arthroscopy procedure on an unknown date, it was observed that there were metal shavings while using the fms curved ultra-aggressive blade plus 4.2mm 5pk device.Another like device was used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as approprate.Investigation summary: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the inner shaft of the burr has a plastic sleeve which is part of the burr assembly, the sleeve is showing slipped and wrinkled.The distal part of the inner shaft shows marks of friction due to the sleeve failure.A manufacturing record evaluation was performed for the finished device 9l92646 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, the reported complaint can be confirmed.The plastic sleeve is part of the burr assembly and is intended to provide stability and lubrication to the burr.A possible root cause for the reported issue can be attributed to the handling of the device, higher speeds applied on the handpiece can increase the temperature of the device's shaft, lack of adequate irrigation and excessive side loading can contribute to a slipped sleeve, as per ifu: adequate irrigation to the tip of the blade or burr is required to cool the blade and prevent accumulation of excised material in the surgical site.Excessive side loading may result in blade wear and degradation, as well as clogging and/or seizing.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: FMS CURVED ULTRA-AGGRESSIVE BLADE PLUS 4.2MM 5PK
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17088236
• Report Number: 1221934-2023-02348
• Device Sequence Number: 14995555
• Product Code: HRX
• UDI-Device Identifier: 10886705025909
• UDI-Public: 10886705025909
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 283422
• Device Catalogue Number: 283422
• Device Lot Number: 9L92646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown